Sinusitis
Conditions
Keywords
Merocel Middle Meatus Spacers, Silastic Middle Meatus Spacers, Functional Endoscopic Sinus Surgery
Brief summary
Functional endoscopic sinus surgery (FESS) is the best method of surgically treating patients who suffer from sinus disease. Synechiae formation in the nose is the most common complication after sinus surgery. Synechiae describes the adhesion of two opposing mucosal surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage. Spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae. The aim of this study is to see if a silastic spacer is more effective at reducing the formation of synechiae after sinus surgery than a merocel spacer.
Interventions
DEVICESilastic Spacer
The Silastic spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 to 14 days following surgery.
DEVICEMerocel Spacer
The Merocel spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 to 14 days following surgery.
Sponsors
St. Paul's Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over the age of 19 years, currently receiving sinus-related care at the St Paul's Sinus Centre for chronic rhinosinusitis and who undergo primary bilateral complete endoscopic sinus surgery will be approached to participate in this clinical trial.
Exclusion criteria
* Patients with sino-nasal tumors * Patients solely undergoing nasal septal reconstruction * Patients with previous history of endoscopic sinus surgery * Cystic fibrosis or syndromic patients * Patients with autoimmune diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups. | Participants will be followed for the duration of post op standard of care, an expected average of 90 days. | The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence). A senior Rhinologist will endoscopically assess each nasal cavity independently to determine if synechiae exists between the middle turbinate and lateral nasal wall. Count and absolute percentages will be reported. Incidence of postoperative synechiae will be compared between right and left nasal cavities receiving either silastic or glove finger spacers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative synechiae in 6-day versus 14-day postoperative spacer removal groups. | Participants will be followed for the duration of post op standard of care, an expected average of 90 days. | The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence). A senior Rhinologist will endoscopically assess each nasal cavity independently to determine if synechiae exists between the middle turbinate and lateral nasal wall. Count and absolute percentages will be reported. Secondary comparisons of postoperative synechiae will be compared between subjects in the 6-day vs 14-day spacer removal groups. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sinonasal Outcomes Test-22 (SNOT- 22) score. | Participants will be followed for the duration of post op standard of care, an expected average of 90 days. | The SNOT-22 is a sinus-specific questionnaire that evaluates subjective symptoms for patients suffering from chronic rhinosinusitis. SNOT-22 is scored out of 110 (22 questions, up to 5-points each) has demonstrated internal consistency, reliability, discriminate and concurrent validity and responsiveness to change12. Responses will be summated and considered as a continuous, numerical variable. Mean, median, standard deviation and inter-quartile range will be reported. SNOT-22 change between baseline (preoperative score) and 90-days (postoperative score) will be compared between groups having middle meatal spacers removed at 14 days versus 6 days postoperatively. |
Countries
Canada
Outcome results
None listed